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US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...
FDA Will Share Rejection Letters Drugmakers Often Conceal
The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...
FDA publishes drug rejection letters for 15 Massachusetts biotechs
In a bid to increase transparency, the U.S. Food and Drug Administration has begun publishing the complete response letters ...
US FDA publishes 200 rejection letters in transparency push
The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to drugmakers, a significant move to increase transparency of the agency's work.
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FDA, in policy shift, publishes some drug rejection letters
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
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FDA approves Moderna COVID vaccine for kids under 12 at higher risk
Vaccine maker Moderna announced today that the US Food and Drug Administration (FDA) has granted full approval of its ...
Enrollment Initiated in Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs
In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally ...
Seed Recall Update as FDA Issues Highest Risk Warning
The Whole Herb Company Inc. issued a voluntary recall for select lots of its organic whole celery seeds on May 27 due to potential salmonella contamination.
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FDA Issues Early Alert for Medtronic pH Monitoring Capsules
Used for diagnosing gastroesophageal reflux, the devices may not attach or detach correctly, potentially causing serious ...
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Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax, in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease
Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 months through 64 years at increased risk for COVID-19 disease CAMBRIDGE, MA / ACCESS Newswire / July 10, 2025 / ...
FDA Issues Highest Risk Warning For Cucumber Recall
Fuentes Farms LLC announced a voluntary recall of 71 boxes of fresh cucumbers on June 13 due to potential salmonella ...